The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).

Further study details as provided by University of Southern California:

Primary Outcome Measures:

The effect of an anti-VEGF agent, bevacizumab, on growth factor levels in eyes with traction retinal detachment due to PDR. [ Time Frame: Interim anlaysis will be performed (and data will be presented) after n=20 subjects have been enrolled and there is 3 month follow-up data from time of last surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine whether intra- and post-operative complications are decreased in eyes given pre-operative adjunctive bevacizumab in eyes undergoing PDR surgery. [ Time Frame: Interim anlaysis will be performed (and data will be presented) after n=20 subjects have been enrolled and there is 3 month follow-up data from time of last surgery. ] [ Designated as safety issue: No ]

Visual outcomes are improved in patients given pre-operative adjunctive bevacizumab in eyes undergoing PDR surgery. [ Time Frame: Interim anlaysis will be performed (and data will be presented) after n=20 subjects have been enrolled and there is 3 month follow-up data from time of last surgery. ] [ Designated as safety issue: No ]

Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.

Drug: Avastin (bevacizumab)

single 0.05 mL intravitreal injection of bevacizumab 1.25 mg

Other Name: Avastin

Sham Comparator: Sham Injection Group (SIG)

Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.

Other: Sham injection

Subject's eyes will be anesthetized but no injection will be performed.

Other Name: Sham

Detailed Description:

Traction retinal detachment (TRD) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. Fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the eye. Small, nonrandomized studies have suggested that pre-operative adjunctive anti-VEGF administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Active fibrovascular proliferation due to PDR with TRD given pre-operative clearance for pars plana vitrectomy (PPV) and TRD repair.

Exclusion Criteria:

Dense vitreous hemorrhage

Inability to follow-up for surgery within 3-7 days after intravitreal injection

History of stroke, thromboembolic event, or heart attack within the last 6 months

Less than 18 years of age

Pregnancy

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01270542